00:37 , May 10, 2019 |  BC Innovations  |  Product Development

Congress pushes to reform patent eligibility, biotechs say not enough

Congress has taken the first step towards fixing a key problem with patent policy that has crippled the diagnostics industry and disrupted development of other life science inventions, but its proposed solution falls short for...
18:36 , Apr 26, 2019 |  BioCentury  |  Finance

Earnings on deck

Earnings on deck At least 17 profitable biotechs and pharmas are slated to report earnings this week. (A) Fiscal 2Q; (B) During trading hours in Europe; premarket on U.S. exchange Company Date Pre/post mkt 1Q19...
17:47 , Feb 8, 2019 |  BC Week In Review  |  Company News

Vanda sues FDA over 'unnecessary' dog testing requirement

Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) filed suit against FDA requesting a federal court lift a partial clinical hold the agency placed on tradipitant after Vanda refused to conduct a nine-month dog toxicity study. In an open...
23:23 , Feb 6, 2019 |  BC Extra  |  Clinical News

Vanda sues FDA over 'unnecessary' dog testing requirement

Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) filed suit against FDA requesting a federal court lift a partial clinical hold the agency placed on tradipitant after Vanda refused to conduct a nine-month dog toxicity study. In an open...
23:40 , Jan 25, 2019 |  BioCentury  |  Politics, Policy & Law

101 problems with patent eligibility

The U.S. diagnostics industry is being strangled, and other life science inventions are being hobbled by, ill-conceived and contradictory patent policies. The USPTO director has signaled he wants to help, but only Congress has the...
21:18 , Dec 14, 2018 |  BC Week In Review  |  Clinical News

Vanda's tradipitant meets in Phase II for gastroparesis

Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) said tradipitant met the primary endpoint in the Phase II VLY-686-2301 trial to treat idiopathic and diabetic gastroparesis. The company plans to meet with regulatory authorities in the near future to...
00:48 , Oct 6, 2018 |  BioCentury  |  Finance

Seeking validation

The final stretch of the year offers clinical catalysts and early launch data that could validate investments in hot immuno-oncology targets and large untapped markets. Late-stage readouts from Vertex Pharmaceuticals Inc. in cystic fibrosis and...
21:03 , Aug 13, 2018 |  BC Extra  |  Company News

Management tracks: FDA, Allergan

Patrick Frey will depart as chief of staff in FDA’s Office of New Drugs (OND) on Aug. 24 to become director of global regulatory policy and R&D at Amgen Inc. (NASDAQ:AMGN). Khushboo Sharma becomes OND’s...
17:18 , Mar 9, 2018 |  BC Week In Review  |  Clinical News

Vanda's Hetlioz meets in Phase III for jet lag disorder

Vanda Pharmaceuticals Inc. (NASDAQ:VNDA) reported data from the double-blind, U.S. Phase III JET8 trial in 318 healthy volunteers undergoing a circadian challenge of an eight hour advance to their usual bedtime to induce jet lag...
23:52 , Oct 6, 2017 |  BioCentury  |  Finance

Bargain shopping

With all companies valued over $1 billion increasing a median of at least 16.8% in 1H17, investors went bargain shopping in the $500-$999 million tier in 3Q17. The group outperformed all other market cap bands,...